Feeling of Caregivers After a Palliative Management of Extreme Premature Babies in Delivery Room.

Recruiting

• Conditions: Caregiver Feeling

• Registration Number: NCT06458114
• Lead Sponsor: CHU de Reims

Brief Summary

Introduction :

The birth of a child is usually a happy event that caregivers working in delivery rooms share with families.

Unfortunately, newborns sometimes need palliative care as soon as birth occurs.

In France, neonates who were liveborn under 24+0 weeks amenorrhea (date of last mentrual period) or weighing less than 500 grams) usually have non resuscitation in delivery room \[Ancel 2020\]. Some of them are considered as viable (referring to World Health Organisation definition : either term ≥ 22 + 0 amenorrhea week or birth weight ≥ 500 grams), others as nonviable (term \< 22 AW and birth weight ≤500 grams).

In France, legislative development over last two decades have allowed the emergence of palliative care in delivery room. In a French survey in 2016, 83% of maternities were confronted at least once a year with this situation.

Detailed Description

In France as in other countries, published studies concerning palliative care for extremely premature babies focused on the " grey zon " period, but not on the nonviable preterm infants (also called late miscarriage) who have signs of life at birth. Only a fairly recent French book of 735 pages exclusively dedicated to the palliative approach in perinatal medicine, reports in a single chapter the existence of palliative care in extremely non-viable premature newborns.

There is a paucity of articles about the actual experience of caregivers confronted to palliative care of extremely preterm babies, viable or non viable, primarily studies in the so-called "gray" literature. Thus, a midwifery graduation thesis describes the experience of midwives in a French university hospital following the care of babies born alive between 18 and 24 weeks old . Two recent reviews explore the notion of resilience of caregivers who have been involved in perinatal palliative care . A nursing graduation dissertation explores the emotions of caregivers faced with perinatal bereavement .

Primary objective: the primary objective of this both qualitative and quantitative monocentric study is to explore the feelings of caregivers (doctors, midwifes, nurse's aids, pediatric nurses) within 2 months of a palliative situation for an extremely preterm baby in a delivery room, viable or not, and not eligible for resuscitation.

Secondary objective: the secondary objective of the study is to quantify the impact of this stressful event:

* Within the first month (acute stress).

* 2 months after the event (post-traumatic stress).

Expected impact of the study:

* These care situations are not described in the scientific literature and little described in the so-called grey literature: this study aims to make them readable.

* The caregiver's feelings and the mechanisms that underlie them may differ, depending on the type of profession and links within a team: this study aims to better characterize and understand them.

* As a result, the investigators hope this study will identify avenues for work and action to better support caregivers and prevent work-related burnout.

Study Timeline

• Study Start: 2022-05-07
• Status Verified: 2024-06
• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-13
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Any caregiver working at the Universitary Hospital of Reims (France) (pediatrician, obstetrician, midwife, midwife, nurse's aide, pediatric nurse, midwife student, peidatrician student).
• who cared for an extremely preterm newborn in a delivery room, with a palliative approach,
• and gave his/her consent.
• The baby must have shown at least minimal signs of vitality (that is : heartbeats, cry, respiratory movements, painful facies, gasps).
• The caregiver must has been physically present with either the newbor, or the mother, or both.

Exclusion Criteria : none

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of caregiver feeling	1 month	Semi-directional interviews will be carried out with the identification of the main themes during the verbatim transcription (qualitative study).

Secondary Outcome Measures

Name	Time	Method
Assessment of stress	2 months	Revised Impact of Event Scale (IES-R) \[Weiss, Brunet\] scale

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France